PS-341 in Treating Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced cancer.
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific||Drug: bortezomib||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Patients With Advanced Solid Tumors and B-cell Lymphoproliferative Disorders|
|Study Start Date:||November 1999|
|Study Completion Date:||August 2003|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose and toxicity of PS-341 in patients with advanced malignancies.
- Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
- Regimen A: Patients receive PS-341 IV twice weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3-4 or 2 of 6 patients experience dose-limiting toxicity.
- Regimen B: Once the MTD has been determined in regimen A, patients receive PS-341 IV twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 14 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006362
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Alex A. Adjei, MD, PhD||Mayo Clinic|